Diagnostic and therapeutic standard of primary liver cancer (2011 version) (4) Diagnostic standard of hepatocellular carcinoma. 1. Pathological diagnostic standard: HCC is diagnosed by biopsy or surgical resection of tissue specimens from liver occupying foci or extra-hepatic metastases, and diagnosed by pathological histological and/or cytological examination, which is the gold standard. Yuehua Wang, Department of General Surgery, Xuanwu Hospital of Capital Medical University, Beijing, China 2. Clinical diagnostic criteria: among all solid tumors, HCC is the only one that can be diagnosed by clinical diagnostic criteria, which is recognized both domestically and internationally as non-invasive, simple, convenient and operable, and it is generally believed that it depends mainly on three major factors, i.e., the background of chronic liver disease, the results of imaging examinations and the level of serum AFP; however, there are differences in the understanding of academics and their specific requirements, which often change, and the practical application is also different. However, academic understanding and specific requirements are different and often change, and there are errors in practical application. Therefore, taking into account China’s national conditions, previous domestic standards and clinical practice, the expert group proposes that it is appropriate to strictly control and jointly analyze the requirements, and that the clinical diagnosis of HCC can be established when two of the following conditions (1)+(2)a or three of the following conditions are met: (1) Cirrhosis and HBV and/or HCV infection. (1) evidence of cirrhosis and HBV and/or HCV infection (HBV and/or HCV antigen positivity); (2) typical imaging features of HCC: simultaneous multislice CT scans and/or dynamic contrast-enhanced MRIs showing hepatic spaces with rapid heterogeneous hypervascularity in the arterial phase and venous or delayed phase washout. phase washout ). If the diameter of liver occupation is ≥2cm, and one of the two imaging examinations, CT and MRI, shows that the liver occupation has the characteristics of hepatocellular carcinoma as mentioned above, then the diagnosis of HCC can be made; ② If the diameter of liver occupation is 1-2cm, then the diagnosis of HCC can be made only when both imaging examinations, CT and MRI, show the characteristics of hepatocellular carcinoma as mentioned above, so as to enhance the specificity of diagnosis. (3) Serum AFP ≥ 400 μg/L for 1 month or ≥ 200 μg/L for 2 months, and other causes of AFP elevation can be ruled out, including pregnancy, tumors of embryonic origin in the germ line, active liver disease and secondary liver cancer. 3.Precautions and instructions. (1) Several foreign guidelines (including AASLD,EASL and NCCN’s CPGs) emphasize that multi-row CT scanning and/or dynamic contrast-enhanced MRI should be performed for liver occupancy and should be performed in experienced imaging centers; at the same time, it is believed that a definitive imaging diagnosis of HCC requires four-phase scanning examinations in the plain, arterial, venous and delayed phases, and the lesion HCC is characterized by early arterial enhancement and higher density than normal liver tissue, and rapid disappearance of venous enhancement and lower density than surrounding normal liver tissue. If the imaging characteristics of liver occupancy are atypical, or the two examinations of CT and MRI are inconsistent, liver puncture biopsy should be carried out, but even if the negative results can not be completely ruled out, it is still necessary to follow up and observe. (2) In recent years, clinical observations and research results at home and abroad suggest that serum AFP can be elevated in some patients with ICC and liver metastasis of gastrointestinal cancer, and ICC is often accompanied by cirrhosis. Although the incidence of ICC is much lower than that of HCC, both of them are common in patients with cirrhosis, therefore, hepatic space-occupying lesions with elevated AFP are not necessarily HCC, and need to be carefully differentiated. In China and most countries in the Asia-Pacific region, patients with significantly elevated AFP are mostly HCC, which still has differential value compared with ICC, so it is used as a diagnostic index of HCC. (3) For patients with serum AFP ≥ 400 μg/L and no liver occupancy detected by ultrasound, care should be taken to exclude pregnancy, germline tumors of embryonic origin, active liver disease, and gastrointestinal hepatoid adenocarcinoma, etc.; if it can be excluded, a multislice CT and/or dynamic contrast-enhanced MRI scan must be performed in a timely manner. The diagnosis of HCC is made if typical imaging features of HCC are present (abundant vascularity in the arterial phase that subsides in the portal or delayed phase); if the findings or vascularity are not typical, contrast-enhanced examination should be performed using other imaging modalities or a liver biopsy of the lesion should be performed. Arterial phase enhancement alone without venous phase regression is not sufficient evidence for the diagnosis of HCC. If AFP is elevated but not at diagnostic level, in addition to the above conditions that may cause AFP increase should be excluded, AFP changes must be closely observed and followed up by shortening the interval of ultrasound examination to 1-2 months, and performing CT and/or MRI for dynamic observation when needed. If hepatocellular carcinoma is highly suspected, selective hepatic arteriography (DSA) is recommended, and liver puncture biopsy can be performed if necessary. (4) For those who have liver-occupying lesions without elevated serum AFP and no imaging features of hepatocellular carcinoma, if the diameter is <1cm, close observation can be made. If the liver occupancy does not show vascular enhancement in dynamic imaging, malignancy is unlikely. If the occupancy gradually increases or reaches a diameter of ≥2 cm, further examination such as ultrasound-guided liver puncture biopsy should be performed. Even if the liver biopsy result is negative, it should not be easily dismissed and should be tracked and followed up; imaging follow-up should be carried out at 6-month intervals until the lesion disappears, enlarges, or presents the diagnostic features of HCC; if the lesion enlarges but still does not have the typical changes of HCC, repeat liver biopsy can be considered. (5) It should be pointed out that 5%-20% of HCC patients in China do not have a background of cirrhosis, about 10% of patients do not have evidence of HBV/HCV infection, and about 30% of patients have a serum AFP consistently <200 μg/L; at the same time, most of the HCC on imaging has the characteristic of vascularization, but there are a small number of patients who have a lack of vascularity. In addition, in Europe and the United States, patients with non-alcoholic steatohepatitis (NASH) can develop cirrhosis and then HCC (NASH-related HCC), which has been reported, but there is a lack of relevant data in China. (E) Differential diagnosis. 1. When serum AFP is positive, HCC should be differentiated from the following diseases: (1) chronic liver disease: such as hepatitis, cirrhosis, the patient's serum AFP level should be observed dynamically. When liver disease is active, AFP is mostly active in the same direction as ALT, and it is mostly transiently elevated or repeatedly fluctuating, usually not more than 400μg/L, and for a short period of time. Combined with liver function tests, comprehensive observation and analysis should be made. If the curves of AFP and ALT are separated, AFP rises while SGPT falls, i.e., AFP and ALT are anisotropic and/or AFP is persistently high, the possibility of HCC should be alerted. (2) Tumors of gestational, gonadal or embryonic type, etc.: Identification is mainly through history, physical examination, abdominopelvic ultrasound and CT. (3) Digestive system tumors: some adenocarcinomas occurring in the gastrointestinal and pancreatic glands can also cause elevated serum AFP, which is called hepatoid adenocarcinoma. In differential diagnosis, in addition to detailed understanding of medical history, physical examination and imaging examination, the determination of serum AFP heterogeneous body can help to identify the origin of the tumor. For example, in gastric hepatoid adenocarcinoma, AFP is mainly lentil lectin non-conjugated type. 2. When serum AFP is negative, HCC should be differentiated from the following diseases: (1) secondary hepatocellular carcinoma: most commonly seen in metastasis of gastrointestinal tumors, but also commonly seen in lung cancer and breast cancer. Patients may have no background of liver disease, but may have gastrointestinal tumor manifestations such as blood in stool, fullness, anemia, and weight loss. Serum AFP is normal, while gastrointestinal tumor markers such as CEA, CA199, CA50, CA724, and CA242 may be elevated. Imaging characteristics: ① often multiple occupancy, while HCC is mostly solitary; ② typical image of metastatic tumor, can be seen "bull's-eye sign" (swelling periphery has a halo, the central lack of blood supply and hypoechoic or hypodense); ③ Enhanced CT or DSA imaging can be seen in the tumor with fewer blood vessels, the blood supply is not as rich as that of HCC; ④ digestive endoscopy or X-ray imaging examination may find that the tumor has a low vascularity, and the blood supply is not as rich as that of HCC. (iv) Gastrointestinal endoscopy or X-ray imaging may reveal primary cancerous focal lesions in the gastrointestinal tract. (2) Intrahepatic cholangiocarcinoma (ICC): it is a rare pathologic type of primary liver cancer, with a prevalence at the age of 30-50 years. Clinical symptoms are nonspecific, most of the patients have no background of liver disease, and most of them do not have a high AFP, while tumor markers such as CEA and CA199 may also be elevated. Imaging CT scan often shows lobulated or rounded low-density areas of different sizes, with uneven density and fuzzy or unclear edges. However, the most meaningful is that CT enhancement scan shows that the blood supply of the liver is not as rich as that of HCC, and the fibrous component is more, with delayed enhancement phenomenon, which is characterized by the feature of "fast in and slow out", and the periphery of the liver is sometimes seen as irregular intrahepatic bile ducts, and the periphery of the liver is not as rich as that of the liver. Sometimes, irregular dilatation of intrahepatic bile ducts can be seen; there can also be local atrophy of liver lobes, hepatic peritoneum is invaginated, and sometimes there are linear high-density shadows in the liver tumor parenchyma (linear sign). The diagnosis rate of imaging examination is not high, and it mainly relies on post-surgical pathologic examination for confirmation. (3) Hepatic sarcoma: there is often no background of liver disease, and the imaging examination shows homogeneous solid occupancy with rich blood supply, which is not easy to be distinguished from AFP-negative HCC. (4) benign liver lesions: including: (1) hepatic adenoma: often without liver disease background, female, often with a history of oral contraceptive use, and highly differentiated HCC is not easy to distinguish, the more meaningful test is 99mTc nuclide scanning, hepatic adenomas can uptake nuclides and delayed-phase manifestation of a strong positive image; (2) hepatic hemangiomas: often without liver disease background, female, CT enhancement scanning can be seen from the periphery of the occupying space to strengthen the filling, showing a "fast and slow", and "fast and slow". (ii) Liver hemangioma: usually no liver disease background, more women, CT enhancement scan can be seen from the periphery of the occupation began to strengthen and fill, was "fast in and slow out", and HCC's "fast in and fast out" distinction, MRI can be seen as a typical "light bulb sign"; (iii) Liver abscess: often dysentery or septic disease history without liver disease history, has or had infection manifestations, and has or has had a strong positive picture (iii) Liver abscess: often have history of dysentery or septic disease but no history of liver disease, have or had infection manifestation, fever, peripheral blood leukocytes and neutrophilia, etc., the corresponding part of the chest wall of the abscess often have limited edema, pressure and pain and right epigastric muscle tension, etc. Ultrasonography in the non-liquefaction or pus consistency is often confused with hepatocellular carcinoma, and in the liquefaction of the liquid dark area, which should be differentiated from hepatocellular carcinoma with the central necrosis; DSA imaging without tumor vascularity and staining. If necessary, fine needle puncture can be made at the pressure point. Anti-amoeba test treatment is a better differential diagnosis method. Liver worms: progressive enlargement of liver, hard texture and nodularity, most of the liver is destroyed in the late stage, and the clinical manifestations can be very similar to hepatocellular carcinoma; however, the disease usually has a long course, often with a history of many years, and progresses slowly, and tremor on percussion, i.e., "cystic fibrillation of the worms" is the characteristic manifestation, and it is often found that there is a history of living in popular pasture areas and contacting with dogs and goats, and it is often found that there is a history of living in popular pasture areas and contacting with dogs and goats. The intradermal test (Casoni test) is a specific test, with a positive rate of 90%-95%, and ultrasound can find strong echoes of floating cysts in the cystic cavity, and CT can sometimes see calcified head knots in the cystic wall. Because it can induce severe allergic reaction, it is not suitable for puncture biopsy.